RecruitingPhase 4NCT06602622

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR/3TC/TDF At 48 Weeks

Sponsor

Instituto Mexicano del Seguro Social

Enrollment

108 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

HIV HIV Associate Weight Loss

Summary

Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy (ART) for at least 36 months, treated with second generation integrase inhibitors (BIC/TAF/FTC, DTG/ABC/3Tc or DTG+TDF/FTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg/m2 and body fat greater than 20% will be eligible to participate in this clinical trial. If they decide to participate, they will sign an informed consent. After this, a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART (listed in the guidelines as one of the main lines of treatment) containing doravirine/lamivudine/disoproxil fumarate tenofovir. Medical visits will be at 1 month, 3 months, 6 months, 9 months, and 12 months after get in to this protocol, with laboratory studies that evaluate fats, blood sugar, liver function, kidney function, and test for HIV control; in addition, each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression, anxiety, insomnia, satisfaction with treatment or symptoms associated with it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people living with HIV who have gained unintended weight while on integrase inhibitor (INSTI)-based antiretroviral therapy can lose weight by switching to a different antiretroviral regimen called DOR/3TC/TDF (doravirine/lamivudine/tenofovir disoproxil fumarate). **You may be eligible if...** - You are living with HIV and have had an undetectable viral load for at least 48 weeks - You are currently on one of three specific integrase-based regimens (BIC/FTC/TAF, DTG/3TC/ABC, or DTG+TDF/FTC) - Your BMI is 25 or higher and body fat is above 20% - You have gained more than 10% of your body weight unintentionally within 1–3 years of starting your current regimen - Your kidney function is adequate (GFR ≥ 60 mL/min) - Your HIV viral load is below 50 copies/mL at screening **You may NOT be eligible if...** - You have a history of failing on integrase inhibitors - You plan to add or change medications that cause significant weight change during the study - You recently changed doses of antipsychotics, antidepressants, thyroid medications, or diabetes medications - Your weight gain has another clear medical explanation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntegrase inhibitor

Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine 300 mg (DTG/ABC/3TC); 3) DTG 50mg+TDF 300mg/FTC 200mg (DTG+TDF/FTC) Each will be prescribed one tablet every day during 48 weeks

DRUGDoravirine + tenofovir DF + lamivudine

Individuals who meet the selection criteria will be randomized to maintain their same regimen with second-generation integrase inhibitors or switch to DOR/TDF/3TC 100/ 300/300 mg It will be prescribed one tablet every day during 48 weeks